Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Richard E. Engler, Ph.D.

On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA.  EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing.  EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.

EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:

  1. Verify the asserted CBI claims are correct and consistent; and
  2. Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.  

Commentary

EPA does not specify how long after submission the documents may be posted, but submitters should expect a very short turn-around.  Bergeson & Campbell, P.C. (B&C®) has addressed the topic of CBI before, most recently on our podcast, All Things Chemical™.  When completing a PMN, a submitter must take care to ensure that all information that must be protected as CBI is marked as such.  A submitter cannot expect EPA to extrapolate a claim for CBI in one part of a form to the rest of the document and its attachments.  B&C strongly suggests that a submitter review the sanitized form of an entire document (e.g., a PMN and its attachments) to ensure that all sensitive information is redacted before submitting the document to EPA.

Do not wait until May 30.  Begin developing and practicing good CBI practices today.


 

By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders.  During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs.  The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk.  The final rule will become effective on June 4, 2019.  Please see our full memorandum for more information on this final rule.


 

By Lynn L. Bergeson and Margaret R. Graham

On February 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its notice extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018.  84 Fed. Reg. 2851.  The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3).  The duration of the extension period is a total of 33 days, but the notice states that because the extension is less than 90 days, EPA reserves the right under TSCA Section 5(c) to issue, for good cause, future additional extensions for individual cases up to a total of 90 days.

More information on why EPA has chosen to do this is in our blog item regarding the pre-publication version of this notice “EPA Extends Review Periods for TSCA Section 5 PMNs, SNUNs, MCANs and Exemption Notices Due to Lack of Authorized Funding and Shutdown.”


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham

On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018.  

Due to a lack of authorized funding, from December 29, 2018, until EPA operations for the TSCA New Chemicals operations fully resumed on January 31, 2019, certain EPA functions were suspended including the processing of submissions made through the Central Data Exchange (CDX), e-PMN, or other methods.  Further, no review work was performed on the TSCA section 5 notifications received by EPA on or before December 29, 2018, and for which the review period had not yet expired as of December 29, 2018.  Consequently, the review period for any TSCA Section 5 notice submitted during the shutdown did not begin until TSCA New Chemical operations fully resumed on January 31, 2019.

EPA states that the duration of the extension period will be a total of 33 days, which is equivalent to the duration of the time period from December 29, 2018 (the date on which certain EPA operations shutdown) and the date on which EPA operations for the TSCA New Chemicals Program fully resumed (January 31, 2019).  The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3).  


 

By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders.  For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule.  The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  Comments on the proposed SNURs are due November 15, 2018.

Please see the full memorandum for more information on the proposed rule and an illuminating commentary.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA).  The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 43527.  The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs.  83 Fed. Reg. 43538.  In each rule, EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  Both direct final rules will be effective on October 26, 2018.  Written adverse comments on one or more of the SNURs must be received by September 26, 2018.  If EPA receives written adverse comments, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of the direct final rules before their effective date.  In addition to the direct final rules, EPA published proposed rules for both the direct final rules.  83 Fed. Reg. 43606, 83 Fed. Reg. 43607.  Comments on the proposed rules are due September 26, 2018.


 

By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton

On August 1, 2018, the U.S. Environmental Protection Agency (EPA) issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 37702.  EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of these 145 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination.  The rule will be effective on October 1, 2018.  Written adverse comment must be received by August 31, 2018.  If EPA receives timely written adverse comment on one or more of the SNURs, it will withdraw the relevant section(s) of the direct final rule.

Please see the full memorandum for more information on this rulemaking and a commentary that details a few of the differences specific to these SNURs.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances.  EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations -- Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada.  EPA, ECCC, and HC previously collaborated in the implementation of a Regulatory Cooperation Council (RCC) Work Plan on Chemicals Management that focused on SNURs and SNAcs.  The primer states that an overarching issue identified during the roundtable discussions was the need for improved outreach and education, ranging from the basics of the SNUR/SNAc programs to specific requirements for various stakeholders, especially for potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche companies in the U.S. and Canada.  According to EPA, information in the primer will assist the regulated community to determine how to comply and engage their supply chains to help facilitate compliance for meeting SNUR and SNAc requirements.  The primer notes that it does not substitute for any SNUR or SNAc provisions, nor is it a rule itself.  The primer does not impose legally binding requirements on the regulated community or on EPA, ECCC, or HC.


 

By Richard E. Engler, Ph.D., Lynn L. Bergeson, Kathleen M. Roberts, and Lauren M. Graham, Ph.D.

On December 6, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened a much anticipated public meeting on implementing changes to the new chemicals review program under the amended Toxic Substances Control Act (TSCA).  EPA offered brief prepared remarks and previously solicited questions from stakeholders.  Stakeholders expressed their appreciation to EPA for developing the draft Points to Consider and related documents made available in advance of the meeting, and for OPPT’s continuing interest on new chemical issues.  For more information, see our blog “EPA Posts Agenda and Other Meeting Materials for December 6, 2017, New Chemicals Review Program Implementation Meeting.”  Below are some key takeaways regarding the meeting as related to EPA’s presentations and input from industry and non-governmental organizations (NGO).

Conditions of Use, SNURs, and PMNs:  EPA stated that one of its main concerns is when EPA does not identify unreasonable risk for intended use, but nonetheless has concerns with reasonably foreseen conditions of use. EPA stated that it will assess whether those concerns can be addressed through significant new use rules (SNUR) that it would promulgate prior to making its Section 5 finding.  EPA stated that, in identifying reasonably foreseeable uses, it will rely on knowledge, experience, and facts to support what is foreseen, not simply what is possible.  Several commenters requested clarification and examples on the information that will support such identifications.  This is plainly an area of intense interest and on which EPA pledged to clarify.

EPA confirmed that the SNUR would mirror the premanufacture notice (PMN) in a way that would clearly state what deviations would be permitted to ensure protections for portions of the PMN about which EPA had identified concerns.  In response to a direct question, Jeff Morris, Ph.D., OPPT Director, confirmed that he personally is looking at each new chemical notification decision to ensure a consistent and coherent approach to chemical reviews.  Dr. Morris assured stakeholders that his engagement would not slow down the PMN review process.

NGO groups, that were ably represented at the meeting, expressed disappointment that they were not a part of the pilot testing component of the new chemicals Points to Consider document. OPPT clarified that the purpose of the pilot was to have parties who are actually preparing PMNs pilot use of the document while preparing PMNs and that as a result, non-PMN submitters were not a part of the pilot.  Following a request from several NGOs, EPA stated that it would of course make the original and redline versions of the Points to Consider document publicly available to ensure full transparency.  Several NGOs also voiced concern with the delay of EPA getting PMN information posted online.  Commenters noted the need for access to more content related to the new chemicals review, such as detailed PMN determinations, as the determinations that are publicly available at this point are boilerplate. Interestingly, concerns were expressed on issues not germane to the workshop, such as existing and accidental releases of chemicals (not related to TSCA).

Of the parties that weighed in on the issue, industry representatives who addressed the issue were supportive of using SNURs to cover reasonably foreseeable conditions of use that are not reflected in the submitted PMNs.  Some NGOs were supportive of the use of SNURs to reduce consent orders, while others stated that SNURs are not an adequate substitute for consent orders and that Congress intended for Section 5(e) orders to come first and to trigger SNURs.  The concern over the use of SNURs rather than consent orders may relate to a concern of chemicals being introduced prior to the SNUR being published in final.  Industry representatives also suggested that EPA seek to scale its information needs appropriately.  For instance, less detailed exposure information should be required for EPA to determine that it has sufficient information on a low hazard chemical.  Similarly, EPA should adjust the hazard profile requirements for a chemical with low exposure.

Chemical Categories:  EPA reviewed the ongoing effort to develop four new chemical categories that could be used in future new chemical reviews.  These are:

  1. Lung Effects Categories:  Polycationic substances (cationic binding); general surfactants; waterproofing agents; and insoluble polymer lung overload;
  2. Photo-Acid Generators (PAG) Category;
  3. Tracer Chemical; and
  4. Perfluorinated Chemicals.

EPA asked for input and ideas on how to move forward with chemical categories -- either by updating existing categories or reviewing internal data to identify new categories -- and how the information should be presented (e.g., to publish separately or together in one document).

OSHA Focus:  On behalf of the TSCA New Chemicals Coalition (TSCA NCC), Richard E. Engler, Ph.D., Bergeson & Campbell, P.C., provided comments that included feedback to EPA that it needs to develop a consultation process with the U.S. Occupational Safety and Health Administration (OSHA) per the Section 5(f) legislative language.  Dr. Engler suggested that EPA’s assessments could be communicated to submitters and OSHA to inform both on the endpoints of concern and EPA’s assessments of safe exposure limits.  In this way, employers are obligated under the Occupational Safety and Health Act to assess hazards and exposures, provide information to workers, and ensure that exposures are controlled under OSHA’s authority, thereby satisfying EPA’s obligation to regulate “to the extent necessary” to protect such workers.

Sustainable Futures Program:  EPA asked for input as to whether it should continue the Sustainable Futures Program.  Some commenters supported the Sustainable Futures Program; no commenters spoke against it.

The presentations from the meeting are listed below and available online:

EPA’s next public meeting on TSCA’s implementation of Existing Chemicals Prioritization is coming up on December 11, 2017.  More information on this upcoming meeting is available on our blog under key phrase public meeting.


 

By Lynn L. Bergeson and Margaret R. Graham

On July 10, 2017, the U.S. Environmental Protection Agency (EPA) issued a prepublication version of a direct final rule, Significant New Use Rule on Certain Chemical Substances, noting the  issuance of  significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 29 chemical substances that were the subject of premanufacture notices (PMN) and subject to consent orders under TSCA Section 5(e).  These are the first rules with consent orders negotiated under new TSCA.  Persons who intend to manufacture or process any of the chemicals for an activity that is designated as a significant new use (SNU) by this rule must notify EPA at least 90 days before commencing that activity, and the notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Further, “[p]ersons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.”  EPA will be accepting comments on these SNURs; comments will be due 30 days after publication in the Federal Register.  If comment deemed adverse is submitted after the rules are published in the Federal Register as to any of the 29 chemical substances, EPA will withdraw the rule and propose it for comment.  Comment will be due 30 days after publication.

EPA states it is issuing these SNURs for specific chemical substances which have undergone premanufacture review because it wants to achieve the following objectives with regard to the SNUs designated in this rule:

  1. EPA will receive notice of any person's intent to manufacture or process a TSCA Inventory listed chemical substance for the described significant new use before that activity begins;
  2. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use;
  3. EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs; and
  4. EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA Section 5(e) consent order are subject to similar requirements.

The 29 chemicals are:

  • PMN Number: P-15-310; Chemical name: 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters;
  • PMN Numbers:  P-15-487, P-15-488, P-15-489, P-15-490, and P-15-491; Chemical names: Multi-walled carbon nanotubes (generic);
  • PMN Number:  P-16-165; Chemical name: Propanoic acid, iron (2+) salt (2:1);
  • PMN Numbers:  P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259; Chemical names:  1-Butanaminium, N,N,N-tributyl-, carbonic acid (1:1) (P-16-255), 1-Butanaminium, N,N,N-tributyl-, methyl carbonate (1:1) (P-16-256), 1-Butanaminium,N,N,N-tributyl-, ethyl carbonate (1:1) (P-16-257), 1-Butanaminium, N,N,N-tributyl-,propyl carbonate (1:1) (P-16-258), 1-Butanaminium, N,N,N-tributyl-, and 1-methylethyl carbonate (1:1) (P-16-259); CAS numbers: 17351-62-1(P-16-255), 56294-05-2(P-16-256), 478796-04-2(P-16-257), 1338579-13-7(P-16-258), and 1803407-49-9(P-16-259);
  • PMN Number:  P-16-284; Chemical name:  Anilino substituted bis-triazinyl derivative of 4,4'-diaminostilbene-2,2'- disulfonic acid, mixed amine sodium salt (generic);
  • PMN Numbers:  P-16-309 and P-16-310; Chemical names:  12-Hydroxystearic acid, reaction products with alkylene diamine and alkanoic acid (generic);
  • PMN Number:  P-16-315; Chemical name:  Alkyldiene, polymer, hydroxy terminated alkoxysilylalkylcarbamate (generic);
  • PMN Number:  P-16-323; Chemical name: Alkylaldehyde, reaction products with substituted carbomonocyclesubstituted heteromonocycle-alkylene glycol bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer and alkyl substituted alkanediamine, acetate salts (generic);
  • PMN Numbers:  P-16-330 and P-16-331; Chemical names:  Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[4-isocyanatobenzene] (P-16-330) and Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[isocyanatobenzene] (P-16-331) (generic);
  • PMN Number:  P-16-360; Chemical name:  Poly(oxy-1,2-ethanediyl),.alpha.-(1-oxodocosyl)-.omega.-[(1- oxodocosyl)oxy]-;
  • PMN Number:  P-16-361;  Chemical name: Pulp, cellulose, reaction products with lignin;
  • PMN Numbers:  P-16-365 and P-16-367; Chemical names:  Alkyl carbonate, polymer with, substituted alkanes and substituted heteromonocycle, substituted alkyl acrylate-blocked (generic) (P-16-365) and substituted heteromonocycle, polymer with substituted alkane and ethoxylated alkane, substituted heteromonocycle substituted alkyl ester-blocked (generic) (P-16-367);
  • PMN Number:  P-16-369; Chemical name:  Substituted heteromonocycle, telomer with substituted carbomonocycles, substituted alkyl ester (generic);
  • PMN Number:  P-16-387;  Chemical name:  Aliphatic polycarboxylic acid, polymer with alicyclic polyhydric alcohol and polyoxyalkylene (generic);
  • PMN Number:  P-16-455; Chemical name:  Sodium tungsten oxide;
  • PMN Number:  P-16-503; Chemical name:  Fatty acids, tall-oil, polymers with alkanoic acid, substituted carbomonocycle, alkyl peroxide-initiated (generic); and
  • PMN Number:  P-16-591; Chemical name:  Alkyl bisphenol (generic).

 
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